105 CMR: DEPARTMENT OF PUBLIC HEALTH

Transcription

1 : STANDARDS FOR PROTECTION AGAINST RADIATION : Purpose : Scope : Definitions (A) 105 CMR establishes standards for protection against ionizing radiation resulting from activities conducted pursuant to licenses or registrations issued by the Agency. The requirements of 105 CMR are designed to control the receipt, possession, use, transfer, and disposal of sources of radiation by any licensee or registrant so the total dose to an individual, including doses resulting from all sources of radiation other than background radiation, does not exceed the standards for protection against radiation prescribed in 105 CMR However, nothing in 105 CMR shall be construed as limiting actions that may be necessary to protect health and safety. (B) 105 CMR is issued pursuant to M.G.L. c. 111, 3, 5M, 5N, 5O, 5P. Except as otherwise specifically provided in other Parts of 105 CMR , 105 CMR applies to persons licensed or registered by the Department to receive, possess, use, transfer, or dispose of sources of radiation. The limits in 105 CMR do not apply to doses due to background radiation, to exposure of patients to radiation for the purpose of medical diagnosis or therapy, to exposure from individuals administered radioactive material and released in accordance with 105 CMR or to voluntary participation in medical research programs. As used in 105 CMR , the following definitions apply: Annual Limit on Intake (ALI) means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in one year. ALI is the smaller value of intake of a given radionuclide in one year by Reference Man that would result in a committed effective dose equivalent of 0.05 sievert (5 rem) or a committed dose equivalent of 0.5 sievert (50 rems) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in 105 CMR : Appendix B,, Columns 1 and 2. Class means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance halftimes: for Class D, Days, of less than ten days, for Class W, Weeks, from ten to 100 days, and for Class Y, Years, of greater than 100 days. For purposes of 105 CMR , "lung class" and "inhalation class" are equivalent terms. Declared Pregnant Woman means a woman who has voluntarily informed the licensee or registrant, in writing, of her pregnancy and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant. Derived Air (DAC) means the concentration of a given radionuclide in air which, if breathed by Reference Man for a working year of 2,000 hours under conditions of light work, results in an intake of one ALI. For purposes of 105 CMR , the condition of light work is an inhalation rate of 1.2 cubic meters of air per hour for 2,000 hours in a year. DAC values are given in 105 CMR : Appendix B,, Column 3. Derived Air hour (DAChour) means the product of the concentration of radioactive material in air, expressed as a fraction or multiple of the derived air concentration for each radionuclide, and the time of exposure to that radionuclide, in hours. A licensee may take 2,000 DAChours to represent one ALI, equivalent to a committed effective dose equivalent of 0.05 sievert (5 rems). 3/2/ CMR 314

2 : continued Dosimetry Processor means an individual or an organization that processes and evaluates individual monitoring equipment in order to determine the radiation dose delivered to the monitoring equipment. Inhalation Class see Class. Lung Class see Class. Nationally Tracked Source means a sealed source containing a quantity equal to or greater than Category 1 or Category 2 levels of any radioactive material listed in 105 CMR : Appendix D. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. Category 1 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 1 threshold. Category 2 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 2 threshold but less than the Category 1 threshold. Nonstochastic Effect means a health effect, the severity of which varies with the dose and for which a threshold is believed to exist. Radiationinduced cataract formation is an example of a nonstochastic effect. For purposes of 105 CMR : Deterministic Effect is an equivalent term. Planned Special Exposure means an infrequent exposure to radiation, separate from and in addition to the annual occupational dose limits. Quarter means a period of time equal to ¼ of the year observed by the licensee or registrant, approximately 13 consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters. Reference Man means a hypothetical aggregation of human physical and physiological characteristics determined by international consensus. These characteristics may be used by researchers and public health employees to standardize results of experiments and to relate biological insult to a common base. A description of Reference Man is contained in the International Commission on Radiological Protection report, ICRP Publication 23, Report of the Task Group on Reference Man. Respiratory Protective Device means an apparatus, such as a respirator, used to reduce an individual's intake of airborne radioactive materials. Sanitary Sewerage means a system of public sewers for carrying off waste water and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee or registrant. Stochastic Effect means a health effect that occurs randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Hereditary effects and cancer incidence are examples of stochastic effects. For purposes of 105 CMR : Probabilistic Effect is an equivalent term. Very High Radiation Area means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of 500 rads (five grays) in one hour at one meter from a source of radiation or from any surface that the radiation penetrates. (At very high doses received at high dose rates, units of absorbed dose, gray and rad, are appropriate, rather than units of dose equivalent, sievert and rem.) Weighting Factor W T for an Organ or Tissue (T) means the proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values 3/2/ CMR 315

3 of W T are: 3/2/ CMR 316

4 : continued ORGAN DOSE WEIGHTING FACTORS Organ or Tissue w T Gonads 0.25 Breast 0.15 Red bone marrow 0.12 Lung 0.12 Thyroid 0.03 aces 0.03 Remainder 0.30 * Whole Body 1.00 ** * 0.30 results from 0.06 for each of 5 "remainder" organs, excluding the skin and the lens of the eye, that receive the highest doses. ** For the purpose of weighting the external whole body dose, for adding it to the internal dose, a single weighting factor, w T = 1.0, has been specified. The use of other weighting factors for external exposure will be approved on a casebycase basis until such time as specific guidance is issued Implementation (A) Any existing license or certificate of registration condition that is more restrictive than 105 CMR remains in force until there is an amendment or renewal of the license or registration. (B) If a license or certificate of registration condition exempts a licensee or registrant from a provision of 105 CMR in effect on or before July 9, 1999, it also exempts the licensee or registrant from the corresponding provision of 105 CMR (C) If a license or registration condition cites provisions of 105 CMR in effect prior to July 9, 1999, which do not correspond to any provisions of the revised 105 CMR , the license or registration condition remains in force until there is an amendment or renewal of the license or registration that modifies or removes this condition : Radiation Protection Programs (A) Each licensee or registrant shall develop, document, and implement a radiation protection program sufficient to ensure compliance with the provisions of 105 CMR See 105 CMR for recordkeeping requirements relating to these programs. (B) The licensee or registrant shall use, to the extent practical, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and doses to members of the public that are as low as is reasonably achievable (ALARA). (C) The licensee or registrant shall, at intervals not to exceed 12 months, review the radiation protection program content and implementation. (D) To implement the ALARA requirements of 105 CMR (B), and notwithstanding the requirements in 105 CMR , a constraint on air emissions of radioactive material to the environment, excluding Radon222 and its daughters, shall be established by licensees, such that the individual member of the public likely to receive the highest dose will not be expected to receive a total effective dose equivalent in excess of 0.1 msv (ten mrem) per year from these emissions. If a licensee subject to this requirement exceeds this dose constraint, the licensee shall report the exceedance as provided in 105 CMR and promptly take appropriate corrective action to ensure against recurrence. 3/2/ CMR 317

5 : Occupational Dose Limits for Adults (A) The licensee or registrant shall control the occupational dose to individual adults, except for planned special exposures pursuant to 105 CMR , to the following dose limits: (1) An annual limit, which is the more limiting of: (a) the total effective dose equivalent being equal to.05 sievert (five rems); or (b) the sum of the deep dose equivalent and the committed dose equivalent to any individual organ or tissue other than the lens of the eye being equal to 0.5 sievert (50 rems). (2) The annual limits to the lens of the eye, to the skin, and to the extremities which are: (a) a lens dose equivalent of 0.15 sievert (15 rems); and (b) a shallow dose equivalent of 0.5 sievert (50 rems) to the skin of the whole body or to the skin of any extremity. (B) Doses received in excess of the annual limits, including doses received during accidents, emergencies, and planned special exposures, shall be subtracted from the limits for planned special exposures that the individual may receive during the current year and during the individual's lifetime. See 105 CMR (E)(1) and (2). (C) (1) When the external exposure is determined by measurement with an external personal monitoring device, the deepdose equivalent must be used in place of the effective dose equivalent, unless the effective dose equivalent is determined by a dosimetry method approved by the Agency. The assigned deepdose equivalent must be for the part of the body receiving the highest exposure. The assigned shallowdose equivalent must be the dose averaged over the contiguous ten square centimeters of skin receiving the highest exposure. The deepdose equivalent, lensdose equivalent, and shallowdose equivalent may be assessed from surveys or other radiation measurements for the purpose of demonstrating compliance with the occupational dose limits, if the individual monitoring device was not in the region of highest potential exposure, or the results of individual monitoring are unavailable; (2) When a protective apron is worn while working medical fluoroscopic equipment and monitoring is conducted as specified in 105 CMR (A)(5), the effective dose equivalent for external radiation shall be determined as follows: (a) When only one individual monitoring device is used and it is located at the neck (collar) outside the protective apron, the reported deep dose equivalent shall be the effective dose equivalent for external radiation; or (b) When only one individual monitoring device is used and it is located at the neck (collar) outside the protective apron, and the reported dose exceeds 25% of the limit specified in 105 CMR (A), the reported deep dose equivalent value multiplied by 0.3 shall be the effective dose equivalent for external radiation; or (c) When individual monitoring devices are worn, both under the protective apron at the waist and outside the protective apron at the neck, the effective dose equivalent for external radiation shall be assigned the value of the sum of the deep dose equivalent reported for the individual monitoring device located at the waist under the protective apron multiplied by 1.5 and the deep dose equivalent reported for the individual monitoring device located at the neck outside the protective apron multiplied by (D) Derived air concentration (DAC) and annual limit on intake (ALI) values are specified in 105 CMR : Appendix B, and may be used to determine the individual's dose and to demonstrate compliance with the occupational dose limits. See 105 CMR (E) In addition to the annual dose limits, the licensee shall limit the soluble uranium intake by an individual to ten milligrams in a week in consideration of chemical toxicity. See footnote 3 of 105 CMR : Appendix B. (F) The licensee or registrant shall reduce the dose that an individual may be allowed to receive in the current year by the amount of occupational dose received while employed by any other person during the current year. See 105 CMR (E). 3/2/ CMR 318

6 : Compliance with Requirements for Summation of External and Internal Doses (A) If the licensee is required to monitor pursuant to both 105 CMR (A) and (B), the licensee shall demonstrate compliance with the dose limits by summing external and internal doses. If the licensee or registrant is required to monitor only pursuant to 105 CMR (A) or only pursuant to 105 CMR (B), then summation is not required to demonstrate compliance with the dose limits. The licensee may demonstrate compliance with the requirements for summation of external and internal doses pursuant to 105 CMR (B), (C) and (D). The dose equivalents for the lens of the eye, the skin, and the extremities are not included in the summation, but are subject to separate limits. (B) Intake by Inhalation. If the only intake of radionuclides is by inhalation, the total effective dose equivalent limit is not exceeded if the sum of the deep dose equivalent divided by the total effective dose equivalent limit, and one of the following, does not exceed unity: (1) the sum of the fractions of the inhalation ALI for each radionuclide; (2) the total number of derived air concentrationhours (DAChours) for all radionuclides divided by 2,000; or (3) the sum of the calculated committed effective dose equivalents to all significantly irradiated organs or tissues (T) calculated from bioassay data using appropriate biological models and expressed as a fraction of the annual limit. For purposes of this requirement, an organ or tissue is deemed to be significantly irradiated if, for that organ or tissue, the product of the weighting factors, w T, and the committed dose equivalent, H T,50, per unit intake is greater than 10% of the maximum weighted value of H T,50, that is, w T H T,50, per unit intake for any organ or tissue. (C) Intake by Oral Ingestion. If the occupationally exposed individual receives an intake of radionuclides by ingestion greater than 10% of the applicable ALI, the licensee shall account for this intake and include it in demonstrating compliance with the limits. (D) Intake through Wounds or Absorption through Skin. The licensee shall evaluate and, to the extent practical, account for intakes through wounds or skin absorption. The intake through intact skin has been included in the calculation of DAC for hydrogen3 and does not need to be evaluated : Determination of External Dose from Airborne Radioactive Material (A) Licensees shall, when determining the dose from airborne radioactive material, include the contribution to the deep dose equivalent, lens dose equivalent, and shallow dose equivalent from external exposure to the radioactive cloud. See 105 CMR : Appendix B, footnotes 1 and 2. (B) Airborne radioactivity measurements and DAC values shall not be used as the primary means to assess the deep dose equivalent when the airborne radioactive material includes radionuclides other than noble gases or if the cloud of airborne radioactive material is not relatively uniform. The determination of the deep dose equivalent to an individual shall be based upon measurements using instruments or individual monitoring devices : Determination of Internal Exposure (A) For purposes of assessing dose used to determine compliance with occupational dose equivalent limits, the licensee shall, when required pursuant to 105 CMR , take suitable and timely measurements of: (1) concentrations of radioactive materials in air in work areas; or (2) quantities of radionuclides in the body; or (3) quantities of radionuclides excreted from the body; or (4) combinations of these measurements. (B) Unless respiratory protective equipment is used, as provided in 105 CMR , or the assessment of intake is based on bioassays, the licensee shall assume that an individual inhales radioactive material at the airborne concentration in which the individual is present. 3/2/ CMR 319

7 : continued (C) When specific information on the physical and biochemical properties of the radionuclides taken into the body or the behavior of the material in an individual is known, the licensee may: (1) use that information to calculate the committed effective dose equivalent, and, if used, the licensee shall document that information in the individual's record; (2) upon prior approval of the Agency, adjust the DAC or ALI values to reflect the actual physical and chemical characteristics of airborne radioactive material, for example, aerosol size distribution or density; and, (3) separately assess the contribution of fractional intakes of Class D, W, or Y compounds of a given radionuclide to the committed effective dose equivalent. See 105 CMR : Appendix B. (D) If the licensee chooses to assess intakes of Class Y material using the measurements given in 105 CMR (A)(2) or (3), the licensee may delay the recording and reporting of the assessments for periods up to seven months, unless otherwise required by 105 CMR or 105 CMR This delay permits the licensee to make additional measurements basic to the assessments. (E) If the identity and concentration of each radionuclide in a mixture are known, the fraction of the DAC applicable to the mixture for use in calculating DAChours shall be either: (1) the sum of the ratios of the concentration to the appropriate DAC value, that is, D, W, or Y, from 105 CMR : Appendix B for each radionuclide in the mixture; or, (2) the ratio of the total concentration for all radionuclides in the mixture to the most restrictive DAC value for any radionuclide in the mixture. (F) If the identity of each radionuclide in a mixture is known, but the concentration of one or more of the radionuclides in the mixture is not known, the DAC for the mixture shall be the most restrictive DAC of any radionuclide in the mixture. (G) When a mixture of radionuclides in air exists, a licensee may disregard certain radionuclides in the mixture if: (1) the licensee uses the total activity of the mixture in demonstrating compliance with the dose limits in 105 CMR and in complying with the monitoring requirements in 105 CMR (B); (2) the concentration of any radionuclide disregarded is less than 10% of its DAC; and, (3) the sum of these percentages for all of the radionuclides disregarded in the mixture does not exceed 30%. (H) When determining the committed effective dose equivalent, the following information may be considered: (1) In order to calculate the committed effective dose equivalent, the licensee may assume that the inhalation of one ALI, or an exposure of 2,000 DAChours, results in a committed effective dose equivalent of 0.05 sievert (5 rems) for radionuclides that have their ALIs or DACs based on the committed effective dose equivalent. (2) For an ALI and the associated DAC determined by the nonstochastic organ dose limit of 0.5 sievert (50 rems), the intake of radionuclides that would result in a committed effective dose equivalent of 0.05 sievert (5 rems), that is, the stochastic ALI, is listed in parentheses in 105 CMR : Appendix B,. The licensee may, as a simplifying assumption, use the stochastic ALI to determine committed effective dose equivalent. However, if the licensee uses the stochastic ALI, the licensee shall also demonstrate that the limit in 105 CMR (A)(1)(b) is met : Planned Special Exposures A licensee or registrant may authorize an adult worker to receive doses in addition to and accounted for separately from the doses received under the limits specified in 105 CMR provided that each of the following conditions is satisfied: (A) The licensee or registrant authorizes a planned special exposure only in an exceptional situation when alternatives that might avoid the dose estimated to result from the planned special exposure are unavailable or impractical. 3/2/ CMR 320

8 : continued (B) The licensee or registrant, and employer if the employer is not the licensee or registrant, specifically authorizes the planned special exposure, in writing, before the exposure occurs. (C) Before a planned special exposure, the licensee or registrant ensures that each individual involved is: (1) informed of the purpose of the planned operation; (2) informed of the estimated doses and associated potential risks and specific radiation levels or other conditions that might be involved in performing the task; and (3) instructed in the measures to be taken to keep the dose ALARA considering other risks that may be present. (D) Prior to permitting an individual to participate in a planned special exposure, the licensee or registrant ascertains prior doses as required by 105 CMR (B) during the lifetime of the individual for each individual involved. (E) Subject to 105 CMR (B), the licensee or registrant shall not authorize a planned special exposure that would cause an individual to receive a dose from all planned special exposures and all doses in excess of the limits to exceed: (1) the numerical values of any of the dose limits in 105 CMR (A) in any year; and (2) five times the annual dose limits in 105 CMR (A) during the individual's lifetime. (F) The licensee or registrant maintains records of the conduct of a planned special exposure in accordance with 105 CMR and submits a written report to the Agency in accordance with 105 CMR (G) The licensee or registrant records the best estimate of the dose resulting from the planned special exposure in the individual's record and informs the individual, in writing, of the dose within 30 days from the date of the planned special exposure. The dose from planned special exposures shall not be considered in controlling future occupational dose of the individual pursuant to 105 CMR (A) but shall be included in evaluations required by 105 CMR (D) and (E) : Occupational Dose Limits for Minors The annual occupational dose limits for minors are 10% of the annual occupational dose limits specified for adult workers in 105 CMR : Dose Equivalent to an Embryo/Fetus (A) The licensee or registrant shall ensure that the dose equivalent to an embryo/fetus during the entire pregnancy, due to occupational exposure of a declared pregnant woman, does not exceed five millisieverts (0.5 rems). See 105 CMR for recordkeeping requirements. (B) The licensee or registrant shall make efforts to avoid substantial variation above a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in 105 CMR (A). (C) The dose equivalent to the embryo/fetus is the sum of: (1) the deep dose equivalent to the declared pregnant woman; and (2) the dose equivalent resulting from radionuclides in the embryo/fetus and radionuclides in the declared pregnant woman. (D) If the dose equivalent to the embryo/fetus is found to have exceeded 5.0 msv (0.5 rem), or is within 0.5 msv (0.05 rem) of this dose, by the time the woman declares the pregnancy to the licensee or registrant, the licensee or registrant shall be deemed to be in compliance with 105 CMR (A), if the additional dose to the embryo/fetus does not exceed 0.5 millisievert (0.05 rem) during the remainder of the pregnancy. 3/2/ CMR 321

9 RADIATION DOSE LIMITS : Dose Limits for Individual Members of the Public (A) Each licensee or registrant shall conduct operations so that: (1) the total effective dose equivalent to individual members of the public from the licensed or registered operation does not exceed one millisievert (0.1 rem) in a year, exclusive of the dose contribution from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with 105 CMR , from voluntary participation in medical research programs, and from the licensee's disposal of radioactive material into sanitary sewerage in accordance with 105 CMR ; and (2) the dose in any unrestricted area from external sources exclusive of the dose contributions from patients administered radioactive material and released in accordance with 105 CMR , does not exceed 0.02 millisievert (0.002 rem) in any one hour; and (3) the total effective dose equivalent to individual members of the public from infrequent exposure to radiation from radiation machines does not exceed 5mSv (0.5 rem). (B) If the licensee or registrant permits members of the public to have access to restricted areas, the limits for members of the public continue to apply to those individuals. (C) A licensee, registrant, or an applicant for a license or registration may apply for prior Agency authorization to operate up to an annual dose limit for an individual member of the public of five millisieverts (0.5 rem). This application shall include the following information: (1) demonstration of the need for and the expected duration of operations in excess of the limit in 105 CMR (A); (2) the licensee's or registrant's program to assess and control dose within the five millisieverts (0.5 rem) annual limit; and (3) the procedures to be followed to maintain the dose ALARA. (D) In addition to the requirements of 105 CMR , a licensee subject to the provisions of the U.S. Environmental Protection Agency's generally applicable environmental radiation standards in 40 CFR 190 shall comply with those requirements. (E) The Agency may impose additional restrictions on radiation levels in unrestricted areas and on the total quantity of radionuclides that a licensee may release in effluents in order to restrict the collective dose : Compliance with Dose Limits for Individual Members of the Public (A) The licensee or registrant shall make or cause to be made surveys of radiation levels in unrestricted areas and radioactive materials in effluents released to unrestricted areas to demonstrate compliance with the dose limits for individual members of the public in 105 CMR (B) A licensee or registrant shall show compliance with the annual dose limit in 105 CMR by: (1) demonstrating by measurement or calculation that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed or registered operation does not exceed the annual dose limit; or, (2) demonstrating that: (a) the annual average concentrations of radioactive material released in gaseous and liquid effluents at the boundary of the unrestricted area do not exceed the values specified in 105 CMR : Appendix B, I; and, (b) if an individual were continuously present in an unrestricted area, the dose from external sources would not exceed rem (0.02 millisievert) in an hour and 0.05 rem (0.5 millisievert) in a year. (C) Upon approval from the Agency, the licensee may adjust the effluent concentration values in 105 CMR : Appendix B, I, for members of the public, to take into account the actual physical and chemical characteristics of the effluents, such as, aerosol size distribution, solubility, density, radioactive decay equilibrium, and chemical form. 3/2/ CMR 322

10 : Testing for Leakage or Contamination of Sealed Sources (A) The licensee or registrant in possession of any sealed source shall assure that: (1) Each sealed source, except as specified in 105 CMR (B), is tested for leakage or contamination and the test results are received before the sealed source is put into use unless the licensee or registrant has a certificate from the transferor indicating that the sealed source was tested within six months before transfer to the licensee or registrant. (2) Each sealed source that is not designed to emit alpha particles is tested for leakage or contamination at intervals not to exceed six months or at alternative intervals approved by the Agency, after evaluation of information specified by 105 CMR (N), an Agreement State, a Licensing State, or the U.S. Nuclear Regulatory Commission. (3) Each sealed source that is designed to emit alpha particles is tested for leakage or contamination at intervals not to exceed three months or at alternative intervals approved by the Agency, after evaluation of information specified by 105 CMR (N), an Agreement State, a Licensing State, or the Nuclear Regulatory Commission. (4) For each sealed source that is required to be tested for leakage or contamination, at any other time there is reason to suspect that the sealed source might have been damaged or might be leaking, the licensee or registrant shall assure that the sealed source is tested for leakage or contamination before further use. (5) Tests for leakage for all sealed sources, except brachytherapy sources manufactured to contain radium, shall be capable of detecting the presence of 185 Bq (0.005 µci) of radioactive material on a test sample. Test samples shall be taken from the sealed source or from the surfaces of the container in which the sealed source is stored or mounted on which one might expect contamination to accumulate. For a sealed source contained in a device, test samples are obtained when the source is in the "off" position. (6) The test for leakage for brachytherapy sources manufactured to contain radium shall be capable of detecting an absolute leakage rate of 37 Bq (0.001 µci) of radon222 in a 24 hour period when the collection efficiency for radon222 and its daughters has been determined with respect to collection method, volume and time. (7) Tests for contamination from radium daughters shall be taken on the interior surface of brachytherapy source storage containers and shall be capable of detecting the presence of 185 Bq (0.005 µci) of a radium daughter which has a halflife greater than four days. (B) A licensee or registrant need not perform test for leakage or contamination on the following sealed sources: (1) Sealed sources containing only radioactive material with a halflife of less than 30 days; (2) Sealed sources containing only radioactive material as a gas; (3) Sealed sources containing 3.7 MBq (100 µci) or less of beta or photonemitting material or 370 kbq (10 µci) or less of alphaemitting material; (4) Sealed sources containing only hydrogen3; (5) Seeds of iridium192 encased in nylon ribbon; and (6) Sealed sources, except teletherapy and brachytherapy sources, which are stored, not being used and identified as in storage. The licensee or registrant shall, however, test each such sealed source for leakage or contamination and receive the test results before any use or transfer unless it has been tested for leakage or contamination within 6 months before the date of use or transfer. (C) Tests for leakage or contamination from sealed sources shall be performed by persons specifically authorized by the Agency, an Agreement State, a Licensing State, or the U.S. Nuclear Regulatory Commission to perform such services. (D) Test results shall be kept in units of becquerel or microcurie and maintained for inspection by the Agency. (E) The following shall be considered evidence that a sealed source is leaking: (1) The presence of 185 Bq (0.005 µci) or more of removable contamination on any test sample. (2) Leakage of 37 Bq (0.001 µci) of radon222 per 24 hours for brachytherapy sources manufactured to contain radium. 3/2/ CMR 323

11 : continued : General (3) The presence of removable contamination resulting from the decay of 185 Bq (0.005 µci) or more of radium. (F) The licensee or registrant shall immediately withdraw a leaking sealed source from use and shall take action to prevent the spread of contamination. The leaking sealed source shall be repaired or disposed of in accordance with this 105 CMR (G) Reports of test results for leaking or contaminated sealed sources shall be made pursuant to 105 CMR SURVEYS AND MONITORING (A) Each licensee or registrant shall make, or cause to be made, surveys that: (1) are necessary for the licensee or registrant to comply with 105 CMR ; (2) are necessary under the circumstances to evaluate: (a) the magnitude and extent of radiation levels; (b) concentrations or quantities of radioactive material; and (c) the potential radiological hazards. (B) The licensee or registrant shall ensure that instruments and equipment used for quantitative radiation measurements, for example, dose rate and effluent monitoring, are calibrated at intervals not to exceed 12 months for the radiation measured except when a more frequent interval is specified in another applicable section of 105 CMR or license condition. (C) All personnel dosimeters, except for direct and indirect reading pocket ionization chambers and those dosimeters used to measure the dose to any extremity, that require processing to determine the radiation dose and that are used by licensees and registrants to comply with 105 CMR , with other applicable provisions of 105 CMR , or with conditions specified in a license or certificate of registration, shall be processed and evaluated by a dosimetry processor: (1) holding current personnel dosimetry accreditation from the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and Technology; and (2) approved in this accreditation process for the type of radiation or radiations included in the NVLAP program that most closely approximates the type of radiation or radiations for which the individual wearing the dosimeter is monitored. (D) The licensee or registrant shall ensure that adequate precautions are taken to prevent a deceptive exposure of an individual monitoring device : Conditions Requiring Individual Monitoring of External and Internal Occupational Dose Each licensee or registrant shall monitor exposures from sources of radiation at levels sufficient to demonstrate compliance with the occupational dose limits of 105 CMR As a minimum: (A) Each licensee or registrant shall monitor occupational exposure to radiation from licensed and unlicensed radiation sources under its control and shall supply and require the use of individual monitoring devices by: (1) adults likely to receive, in one year from sources external to the body, a dose in excess of 10% of the limits in 105 CMR (A); (2) minors likely to receive, in one year from sources external to the body, a deep dose equivalent in excess of one millisievert (0.1 rem) a lens dose equivalent in excess of 1.5 millisievert (0.15 rem), or a shallow dose equivalent to the skin or to the extremities in excess of five millisieverts (0.5 rem); 3/2/ CMR 324

12 : continued (3) Declared pregnant women likely to receive during the entire pregnancy, from radiation sources external to the body, a deep dose equivalent in excess of one millisievert (0.1 rem) [Note: All of the occupational doses in 105 CMR continue to be applicable to the declared pregnant worker as long as the embryo/fetus dose limit is not exceeded]; and (4) individuals entering a high or very high radiation area. (5) Individuals working medical fluoroscopic equipment. (a) An individual monitoring device used for the dose to an embryo/fetus of a declared pregnant woman, pursuant to 105 CMR (A), shall be located under the protective apron at the waist. (b) An individual monitoring device used for lens dose equivalent shall be located at the neck (collar), or an unshielded location closer to the eye, outside the protective apron. (c) When only one individual monitoring device is used to determine the effective dose equivalent for external radiation pursuant to 105 CMR (C)(2), it shall be located at the neck (collar) outside the protective apron. When a second individual monitoring device is used, for the same purpose, it shall be located under the protective apron at the waist. The second individual monitoring device is required for a declared pregnant woman. (B) Each licensee shall monitor, to determine compliance with 105 CMR , the occupational intake of radioactive material by and assess the committed effective dose equivalent to: (1) adults likely to receive, in one year, an intake in excess of 10% of the applicable ALI in 105 CMR : Appendix B,, Columns 1 and 2; and (2) minors likely to receive, in one year, a committed effective dose equivalent in excess of 0.1 millisievert (0.01 rem). (3) declared pregnant women likely to receive, during the entire pregnancy, a committed effective dose equivalent in excess of 1m Sv (0.1 rem). (C) Each licensee or registrant shall ensure that individuals who are required to monitor occupational doses in accordance with 105 CMR (A) wear individual monitoring devices as follows: (1) An individual monitoring device used for monitoring the dose to whole body shall be worn at the unshielded location of the whole body likely to receive the highest exposure. When a protective apron is worn, the location of the individual monitoring device is typically at the neck (collar). (2) An individual monitoring device used for monitoring the dose to an embryo/fetus of a declared pregnant woman, pursuant to 105 CMR (A), shall be located at the waist under any protective apron being worn by the woman. (3) An individual monitoring device used for monitoring lens dose equivalent, to demonstrate compliance with 105 CMR (A)(2)(a), shall be located at the neck (collar), outside any protective apron being worn by the monitored individual, or at an unshielded location closer to the eye. (4) An individual monitoring device used for monitoring the dose to the extremities, to demonstrate compliance with 105 CMR (A)(2)(b), shall be worn on the extremity most likely to receive the highest exposure. Each individual monitoring device shall be oriented to measure the highest dose to the extremity being monitored : Control of Access to High Radiation Areas (A) The licensee or registrant shall ensure that each entrance or access point to a high radiation area has one or more of the following features: (1) a control device that, upon entry into the area, causes the level of radiation to be reduced below that level at which an individual might receive a deep dose equivalent of 0.1 rem (one millisievert) in one hour at 30 centimeters from the source of radiation or from any surface that the radiation penetrates; (2) a control device that energizes a conspicuous visible or audible alarm signal so that the individual entering the high radiation area and the supervisor of the activity are made aware of the entry; or, (3) entryways that are locked, except during periods when access to the areas is required, 3/2/ CMR 325

13 with positive control over each individual entry. 3/2/ CMR 326

14 : continued (B) In place of the controls required by 105 CMR (A) for a high radiation area, the licensee or registrant may substitute continuous direct or electronic surveillance that is capable of preventing unauthorized entry. (C) The licensee or registrant may apply to the Agency for approval of alternative methods for controlling access to high radiation areas. (D) The licensee or registrant shall establish the controls required by 105 CMR (A) and (C) in a way that does not prevent individuals from leaving a high radiation area. (E) The licensee is not required to control each entrance or access point to a room or other area that is a high radiation area solely because of the presence of radioactive materials prepared for transport and packaged and labeled in accordance with the regulations of the U.S. Department of Transportation provided that: (1) the packages do not remain in the area longer than three days; and, (2) the dose rate at one meter from the external surface of any package does not exceed 0.1 millisievert (0.01 rem) per hour. (F) The licensee is not required to control entrance or access to rooms or other areas in hospitals solely because of the presence of patients containing radioactive material, provided that there are personnel in attendance who are taking the necessary precautions to prevent the exposure of individuals to radiation or radioactive material in excess of the established limits in this part and to operate within the ALARA provisions of the licensee's radiation protection program. (G) The registrant is not required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a high radiation area as described in 105 CMR if the registrant has met all the specific requirements for access and control specified in other applicable parts of 105 CMR , such as, 105 CMR for industrial radiography, 105 CMR for xrays in the healing arts, and 105 CMR for particle accelerators : Control of Access to Very High Radiation Areas (A) In addition to the requirements in 105 CMR , the licensee or registrant shall institute measures to ensure that an individual is not able to gain unauthorized or inadvertent access to areas in which radiation levels could be encountered at five grays (500 rads) or more in one hour at one meter from a source of radiation or any surface through which the radiation penetrates at this level. This requirement does not apply to rooms or areas in which diagnostic xray systems are the only source of radiation. (B) The registrant is not required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a very high radiation area as described in 105 CMR (A) if the registrant has met all the specific requirements for access and control specified in other applicable parts of 105 CMR , such as, 105 CMR for industrial radiography, 105 CMR for xrays in the healing arts, and 105 CMR for particle accelerators : Control of Access to Very High Radiation Areas Irradiators (A) 105 CMR applies to licensees with sources of radiation in nonselfshielded irradiators. 105 CMR does not apply to sources of radiation that are used in teletherapy, in industrial radiography, or in completely selfshielded irradiators in which the source of radiation is both stored and operated within the same shielding radiation barrier and, in the designed configuration of the irradiator, is always physically inaccessible to any individual and cannot create high levels of radiation in an area that is accessible to any individual. (B) Each area in which there may exist radiation levels in excess of five grays (500 rads) in one hour at one meter from a source of radiation that is used to irradiate materials shall meet the following requirements: 3/2/ CMR 327

15 : continued (1) Each entrance or access point shall be equipped with entry control devices which: (a) function automatically to prevent any individual from inadvertently entering a very high radiation area; (b) permit deliberate entry into the area only after a control device is actuated that causes the radiation level within the area, from the source of radiation, to be reduced below that at which it would be possible for an individual to receive a deep dose equivalent in excess of one millisievert (0.1 rem) in one hour; and, (c) prevent operation of the source of radiation if it would produce radiation levels in the area that could result in a deep dose equivalent to an individual in excess of one millisievert (0.1 rem) in one hour. (2) Additional control devices shall be provided so that, upon failure of the entry control devices to function as required by 105 CMR (B)(1): (a) the radiation level within the area, from the source of radiation, is reduced below that at which it would be possible for an individual to receive a deep dose equivalent in excess of one millisievert (0.1 rem) in one hour; and, (b) conspicuous visible and audible alarm signals are generated to make an individual attempting to enter the area aware of the hazard and at least one other authorized individual, who is physically present, familiar with the activity, and prepared to render or summon assistance, aware of the failure of the entry control devices. (3) The licensee shall provide control devices so that, upon failure or removal of physical radiation barriers other than the sealed source's shielded storage container: (a) the radiation level from the source of radiation is reduced below that at which it would be possible for an individual to receive a deep dose equivalent in excess of one millisievert (0.1 rem) in one hour; and, (b) conspicuous visible and audible alarm signals are generated to make potentially affected individuals aware of the hazard and the licensee or at least one other individual, who is familiar with the activity and prepared to render or summon assistance, aware of the failure or removal of the physical barrier. (4) When the shield for stored sealed sources is a liquid, the licensee shall provide means to monitor the integrity of the shield and to signal, automatically, loss of adequate shielding. (5) Physical radiation barriers that comprise permanent structural components, such as walls, that have no credible probability of failure or removal in ordinary circumstances, need not meet the requirements of 105 CMR (B)(3) and (B)(4). (6) Each area shall be equipped with devices that will automatically generate conspicuous visible and audible alarm signals to alert personnel in the area before the source of radiation can be put into operation and in time for any individual in the area to operate a clearly identified control device, which must be installed in the area and which can prevent the source of radiation from being put into operation. (7) Each area shall be controlled by use of such administrative procedures and such devices as are necessary to ensure that the area is cleared of personnel prior to each use of the source of radiation. (8) Each area shall be checked by a radiation measurement to ensure that, prior to the first individual's entry into the area after any use of the source of radiation, the radiation level from the source of radiation in the area is below that at which it would be possible for an individual to receive a deep dose equivalent in excess of one millisievert (0.1 rem) in one hour. (9) The entry control devices required in 105 CMR (B)(1) shall be tested for proper functioning. See 105 CMR for recordkeeping requirements. (a) Testing shall be conducted prior to initial operation with the source of radiation on any day, unless operations were continued uninterrupted from the previous day. (b) Testing shall be conducted prior to resumption of operation of the source of radiation after any unintentional interruption. (c) The licensee shall submit and adhere to a schedule for periodic tests of the entry control and warning systems. (10) The licensee shall not conduct operations, other than those necessary to place the source of radiation in safe condition or to effect repairs on controls, unless control devices are functioning properly. 3/2/ CMR 328

16 : continued (11) Entry and exit portals that are used in transporting materials to and from the irradiation area, and that are not intended for use by individuals, shall be controlled by such devices and administrative procedures as are necessary to physically protect and warn against inadvertent entry by any individual through these portals. Exit portals for irradiated materials shall be equipped to detect and signal the presence of any loose radioactive material that is carried toward such an exit and automatically to prevent loose radioactive material from being carried out of the area. (C) Licensees or applicants for licenses for sources of radiation within the purview of 105 CMR (B) which will be used in a variety of positions or in locations, such as open fields or forests, that make it impracticable to comply with certain requirements of 105 CMR (B), such as those for the automatic control of radiation levels, may apply to the Agency for approval of alternative safety measures. Alternative safety measures shall provide personnel protection at least equivalent to those specified in 105 CMR (B). At least one of the alternative measures shall include an entrypreventing interlock control based on a measurement of the radiation that ensures the absence of high radiation levels before an individual can gain access to the area where such sources of radiation are used. (D) The entry control devices required by 105 CMR (B) and (C) shall be established in such a way that no individual will be prevented from leaving the area : Use of Process or Other Engineering Controls The licensee shall use, to the extent practical, process or other engineering controls, such as, containment, decontamination or ventilation, to control the concentrations of radioactive material in air : Use of Other Controls (A) When it is not practicable to apply process or other engineering controls to control the concentrations of radioactive material in air to values below those that define an airborne radioactivity area, the licensee shall, consistent with maintaining the total effective dose equivalent ALARA, increase monitoring and limit intakes by one or more of the following means: (1) control of access; (2) limitation of exposure times; (3) use of respiratory protection equipment; and, (4) other controls. (B) If the licensee performs an ALARA analysis to determine whether or not respirators should be used, the licensee may also consider the impact of respirator use on workers industrial health and safety : Use of Individual Respiratory Protection Equipment If the licensee or registrant uses respiratory protection equipment to limit intakes pursuant to 105 CMR : (A) Except as provided in 105 CMR (A)(2), the licensee or registrant shall use only respiratory protection equipment that is tested and certified by the National Institute for Occupational Safety and Health. (B) If the licensee or registrant wishes to use equipment that has not been tested or certified by the National Institute for Occupational Safety, or for which there is no schedule for testing or certification, the licensee shall submit an application to the Agency for authorization to use this equipment, except as otherwise noted in 105 CMR The application must include evidence that the material and performance characteristics of the equipment are capable of providing the proposed degree of protection under anticipated conditions of use. This must be demonstrated either by the licensee s or registrant s testing or on the basis of reliable test information; 3/2/ CMR 329